Reactions 1173 - 13 Oct 2007

Reported adverse reactions withdeferasirox

Between November 2005 and June 2006, the US FDAreceived 115 reports of suspected adverse drugreactions, in connection with deferasirox [Exjade]. Ofthese reports, 108 were of serious outcomes, includingdeath (19 reports; 17 unduplicated), hospitalisation(74), life-threatening (6) or disabled (4). The reportsinvolved a slightly greater proportion of males thanfemales (54% vs 46%), and ages ranged from 6 to91 years; 37% of the cases reported involved patientsaged ≥ 65 years.

A total of 24 unduplicated reports involved patientswith hepatic adverse events. Included among thesereports were cases of increased aminotransferases,jaundice, subclinical and clinical hepatitis, increasedbilirubin, ascites, hepatic encephalopathy, cholecystitisand liver failure.

In addition, a total of 16 unduplicated case reportsinvolved patients with renal adverse events; theseincluded acute renal failure, renal failure, interstitialnephritis, renal tubulopathy and glomerulonephritis.

Postmarketing reports of haematological adverseevents included agranulocytosis, thrombocytopenia andneutropenia.

The FDA advise that the product labelling fordeferasirox has been updated to reflect the currentinformation regarding acute renal failure and cytopenias,and to provide recommendations to healthcareprofessionals to monitor patients for the presence ofadverse reactions.DEFERASIROX (marketed as Exjade). FDA Drug Safety Newsletter 1: 8-9, No. 1,2007 801052325

1

Reactions 13 Oct 2007 No. 11730114-9954/10/1173-0001/$14.95 Adis © 2010 Springer International Publishing AG. All rights reserved